Quality Assurance and Safety

YCCI has partnered with the Yale Cancer Center to begin a quality assurance and safety monitoring system in order to improve the quality of clinical research at Yale. Investigators with less experience often call on the quality assurance office in the early stages of their studies to get off to a good start. The unit also assists investigators who have been notified that they will undergo an external audit to correct any deficiencies. The office’s expertise is valuable in helping investigators make overall improvements in practices. The quality assurance staff can help investigators make sure they have complied with safety standards for patients participating in clinical trials and ensure that their studies adhere to regulatory compliance and patient safety guidelines.  Part of that support system involves identifying training needs to augment the education provided institutionally.

The role of the Science and Safety Committee (SSC) is to evaluate the scientific merit of clinical research protocols including novelty of the science, impact of the science on the subject area of the protocol, and justification of the utilization of human subjects to answer the scientific question(s) of the protocol. The Committee is also charged with the evaluation of the safety of the protocol with regard to inclusion/exclusion criteria, minimization of risks/maximization of benefits, justification of the research procedures to be utilized, and plans for the provision of overall medical and nursing care for subjects.

2009 SSC Meeting Schedule

Quality Assurance and Safety

• Susan Anderson
  Administrator for Clinical Research Services and Subject Advocacy
  2 Church Street South, Ste 113
  Phone: (203) 785-2902
  susan.anderson@yale.edu